The process of Pad Printing is a common practice among medical device manufacturers to print, mark, and brand uniquely shaped medical devices and components. It usually includes a company’s logo and other distinct markings. This type of printing is usually used on devices that are implantable and/or non-invasive in nature.
Many products manufactured by Biomerics are customized catheter assemblies and require a customized pad printed treatment. In many cases, we use 2 pad printing in-house machines, each with their own advantages and benefits. These machines include the Tosh Logica 03 and the ITW GS-200 Imtran. The Tosh Logica 03 is a numerically controlled 4 color pad printing machine with a radial cliché system, 4 closed ceramic ink cups, rotary table and eyelid shaped guarding. The GS-200 Imtran is capable of printing 2 colors with closed ceramic ink cups. Pad strokes are programmable on both printers and both the Tosh and Imtran machines completely mix the ink on a continuous basis for an evener viscosity through production.
We also use biocompatible inks on many medical devices, including catheters, electro-surgical devices, and other medical and surgical instruments. All of the inks we use are FDA compliant; this is especially important for products that come in contact with the human anatomy. Our printed impressions are tested to assure high adhesion and are impervious to sterilization methodologies such as Ethylene Oxide Sterilization, Gamma Radiation, and Autoclave. We strive to get the best and most up-to-date biocompatible inks because safety is the most important factor in terms of labeling medical devices and products. Biocompatible inks must be sterilization resistant and must not migrate into the human body. We have seen some great results using biocompatible inks including Marabu TPR and TPU inks. They are well suited for critical substrates such as rigid PVC, polystyrene, ABS, and polycarbonate. They have extremely good chemical and mechanical resistances, are fast drying and stress resistance.
It is necessary to get permanent ink adhesion on all medical devices. Ink adhesion is the attachment process of ink to the surface of another rigid material. When printing ink onto rigid plastic, sometimes adhesion can be a problem. Ink adhesion depends on the surface energy of the plastic substrate. The higher the surface energy of the substrate the better the ink adhesion. Optimizing ink adhesion can sometimes be difficult. Surface treating the substrate can help to get better ink adhesion. Biomerics’ has strict quality requirements to ensure the permanent adhesion required in the medical device industry and is applied to all of the products that leave our facility.
Because of the nature of the device being printed, it is important to ensure that pad printing is completed in a clean room environment to ensure both the safety of the product and that it is free from contaminants and other harmful chemicals, debris, etc. These production areas offer proper airflow for ventilation and operators are gowned in clean room attire. Biomerics has over 10 clean room environments in which to provide this and other secondary type processes.
The sky is the limit when it comes to pad printing, and what products you select to print on. Below, are a number of major components that use pad printing, including:
- Various Tubes and Hypotubes
- Heat Shrinks Guide Wires
- Connectors and Components
- Marker bans and depth markers.
We also work with various different prototypes which help to catch potential problems and iron out the details prior to the final full production run.
The size of the print, which is only limited by the ink cup size and the number of colors printed are the only limitations. Printing with more than 4 color prints is possible, but only by printing a portion of the substrate, utilizing all 4 ink cups, and then setting up the pad printer to print additional colors. We’re always ready for new pad printing challenges and we’ll work with our customers until they are satisfied with the end results. With all of our projects, we work to ensure that the best medical grade inks are properly matched for each device application.
We believe that the pad printing process should be tailored to our customer’s needs, not duplicated from someone else’s. That is why we get to know our customers and their culture so that we can better build customized pad printing solutions from the ground up. Our team has the capability to design the tooling, nests, and clichés and then validate the pad printing process parameters. High quality and attention to detail are also great reasons why choosing Biomerics as a choice contract manufacturer can make a difference to your medical device project.
Special thanks to Adnan Hodzic, an Engineering Tech with Biomerics, for his contribution to this blog post.